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FDA Gives Avanos Medical Recall a Class I Label After Reports of Injuries and Deaths

recall
The Food and Drug Administration (FDA) has labeled Avanos Medical’s recall of a system to help place medical feeding tubes a Class I event after dozens of reports of patient injuries and deaths linked to the system. A Class I recall refers to a situation in which there is a reasonable probability that the use of or exposure to a product will cause serious adverse consequences or death. According to an alert issued by the FDA, The company initiated the recall of the Avanos Medical Cortrak 2 Enteral Access System on March 21. Patient injuries and deaths have been reported because of the feeding tubes being placed incorrectly with the use of the system, the FDA’s notice says.

Details of the Recall

If a feeding tube is inserted incorrectly, patients could suffer damage to the vocal cords, lungs or trachea – all of which could lead to serious injury or death. Avanos has reported that there have been 60 injuries and 23 patient deaths related to the misplacement of nasogastric feeding tubes while using the system since 2015, according to the FDA. Avanos’ Cortrak 2 system helps medical personnel place the feeding tubes into the stomach or small intestine of patients who need to receive nutrition through the tube. While the recall only affects 629 units in the U.S., safety issues with the system have increased in the last several years. The FDA has said among patient injury and death reports, adverse events have included collapsed lungs, pneumonia, respiratory failure, excess fluid in the space between the lungs and chest cavity and a hole in the wall of the lung, esophagus or bowel. Avanos sent field correction notice emails to customers with the device on March 18 and March 19. The recall affects devices manufactured between April 1, 2016, and Jan. 1, 2022.

Defective Medical Devices

Medical device manufacturers have a responsibility to make products that are safe for consumers. Not only are patients forced to endure injuries and health consequences as a result of defective devices, but they also face significant financial burdens in the form of medical expenses and lost income, not to mention the anxiety and stress that comes with all of that. If you have suffered adverse health effects or if you have lost a loved one as the result of a defective medical device, you may be able to file a product defect lawsuit against the manufacturer seeking compensation for losses such as medical expenses, lost income, hospitalization, unnecessary surgeries, rehabilitation costs, pain and suffering and emotional distress. An experienced product defect lawyer can help you better understand your legal rights and options. Source: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause

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